Clinical TrialAnxiety DisordersPlaceboCompleted

Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder

This Phase IIa, multi-centre, double-blind, randomised, placebo-controlled trial (n=60) will investigate the safety, tolerability, and efficacy of EMP-01 in adults with social anxiety disorder (SAD). Participants will be randomised 1:1 to receive two administrations of either 225 mg EMP-01 or placebo on Day 1 and Day 29, with the primary endpoint assessed at Day 43.

Target Enrollment
60 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Phase 2, randomized, double-blind, placebo-controlled trial enrolling ~60 adults with DSM-5-TR social anxiety disorder to receive two oral administrations of EMP-01 (225 mg) or matched placebo, 4 weeks apart (Day 1, Day 29).

Primary objective is safety and tolerability; secondary/exploratory objectives include assessment of change in social anxiety symptoms (LSAS, CGI-S) and other clinical measures through Day 43 with monitoring for adverse events.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

EMP-01

experimental

EMP-01 oral capsules, two administrations (Day 1, Day 29).

Interventions

  • Compound225 mg
    via Oral• two doses (Day 1, Day 29)• 2 doses total

    EMP-01 capsules (225 mg) per administration

Placebo

inactive

Matched placebo capsules, two administrations.

Interventions

  • Placebo
    via Oral• two doses (Day 1, Day 29)• 2 doses total

    EMP-01 placebo capsules matched to active

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Eligibility will be assessed at Screening and will be reconfirmed on Day -1 (Baseline) based on available information, before randomization on the following day (Day 1.
  • Participants must meet all of the following criteria to be enrolled in this study:
  • Age
  • 1. Participants must be between 18 and 65 years of age, inclusive, at the time of signing the ICF.
  • Disease Characteristics
  • 2. Has a current diagnosis of SAD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR), which is not better attributable to another psychiatric condition or to a medical condition. The diagnosis will be confirmed by the Mini-International Neuropsychiatric Interview (MINI).
  • 3. Clinician-administered LSAS total score ≥ 70 at Screening and Day -1.
  • 4. Clinician Global Impressions - Severity (CGI-S) score ≥ 4 at Screening and Day-1.
  • Weight
  • 5. Body mass index (BMI) within the range 20-34 kg/m2 (inclusive) at Screening.
  • 6. Able (in the investigator's opinion) to comprehend and be willing to sign an ICF, to abide by the study restrictions, and to attend all study visits.

Exclusion Criteria

  • Exclusion Criteria:
  • Participants who meet any of the following criteria will be excluded from this study:
  • Medical Conditions
  • 1. Has a current or prior DSM-5-TR diagnosis of a schizophrenia spectrum and other psychotic disorder, substance/medication-induced psychotic disorder, bipolar and related disorder, or any disorder with psychotic features (including MDD with psychotic features), as assessed by medical history and a structured clinical interview (MINI).
  • 2. Has a current or prior DSM-5-TR diagnosis of a neurocognitive disorder, intellectual disorder, dissociative disorder, disruptive/impulse-control/conduct disorder, autism spectrum disorder (level 2 or 3), or cluster A and B personality disorder, as assessed by medical history and a structured clinical interview (MINI). Inclusion of individuals with a diagnosis of autism spectrum disorder level 1 may be considered at the discretion of the investigator if the participant no longer meets criteria for the condition and current functioning and/or subthreshold symptoms will not interfere with treatment or compliance in the study.
  • 3. Has a current DMS-5-TR diagnosis of SAD performance only sub-type, PTSD, acute stress disorder, anorexia nervosa, bulimia nervosa, or any other co-morbid psychiatric condition that dominates the clinical presentation and would interfere with experimental treatment.
  • 4. Has a current DMS-5-TR disorder, other than SAD, which is the primary focus of treatment. Note that participants with concurrent GAD are eligible for the study, provided that GAD is not the primary diagnosis. Participants with attention deficit hyperactivity disorder (ADHD) are eligible for the study, provided that they do not require pharmacological treatment for the condition AND if ADHD is not the primary diagnosis.
  • 5. Has severe current depression, as measured by a total score ≥ 16 on the QIDS-SR-16.
  • 6. Has a history of moderate or severe alcohol or cannabis use disorder within 1 year before Screening. Has any severity (including mild) of other substance use disorder (drug) within 1 year before Screening, as confirmed by the MINI.
  • 7. Has had suicidal ideation with some intent to act within 6 months before Screening or a history of suicidal behavior within the past 1 year before Screening.

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2025-03-01
    End: 2025-10-01
  • Compound
    Placebo
  • Topic
    Anxiety Disorders

Locations

MAC Clinical Research - South Staffordshire — Bridgetown, Cannock, Staffordshire, United Kingdom
MAC Clinical Research - Greater Manchester — Manchester, Greater Manchester, United Kingdom
MAC Clinical Research - Lancashire — Blackpool, Lancashire, United Kingdom
MAC Clinical Research - Merseyside — Liverpool, Merseyside, United Kingdom
MAC Clinical Research - South Yorkshire — Tankersley, South Yorkshire, United Kingdom
MAC Clinical Research - Teesside — Thornaby, Stockton-on-Tees, United Kingdom
MAC Clinical Research Centre, West Yorkshire — Leeds, United Kingdom

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